Multiple sclerosis (MS) patients who experienced a relapse between their first and second rounds of Lemtrada (alemtuzumab) had good treatment outcomes over the long run, according to a Phase 3 clinical trial.
Those who relapsed after their first round ended up with annual relapse rates similar to those who didn’t after two years, researchers said at the Consortium of Multiple Sclerosis Centers Annual Meeting. This suggested that an early relapse did not indicate a poor long-term response to Lemtrada.
The presentation was made by researchers from the Missouri Baptist Medical Center‘s Multiple Sclerosis Center for Innovations in Care. It was titled “Durable Efficacy of Alemtuzumab on Clinical and MRI Outcomes over 6 Years in CARE-MS II Patients with Active Relapsing-Remitting Multiple Sclerosis with Relapse Between Courses 1 and 2.” The New Orleans conference, which started May 24, runs until May 27.
The analysis was based on information from the Phase 3 CARE-MS II clinical trial (NCT00548405). Four hundred thirty-five patients received Lemtrada during the trial, which was sponsored by Sanofi-Genzyme and Bayer. Researchers gave patients one of two doses of Lemtrada, and compared the outcomes to treatment with Rebif.
The first Lemtrada course consisted of 12 mg per day for five days. A year later, patients received an additional course for three days.
Twenty-four percent of the 435 patients who received Lemtrada relapsed after the first course. Of these, 83 percent enrolled in an extension trial (NCT00930553) that followed patients for six years from the start of treatment. Eighty-seven percent of those who started the extension completed it.
In this group, the annual relapse rate was 1.2 relapses in the first year. Although 40% relapsed in the second year, the relapse rate dropped to 0.5 relapses per year. Relapse rates continued to drop steadily, reaching 0.2 relapses in the last year of the extension trial.
Sixty percent of patients reported no six-month worsening of their disability during their sixth year. Brain images also supported Lemtrada’s effectiveness, showing that most patients had no new brain lesions. Brain volume loss also decreased after the first year of treatment.
“Outcomes during year 1 of alemtuzumab do not predict longer-term response, as patients who relapsed in year 1 improved markedly over the subsequent five years.” researchers said. “These findings support administering alemtuzumab according to the approved label (two courses) to achieve optimal and durable benefits on clinical/MRI outcomes in the small population of patients experiencing relapse between courses 1 and 2.”